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  • Personalised Health Motor and Cognitive Assistance System for RehAbilitation (PHRASE)

    Stroke-induced motor and cognitive impairments often worsen after hospital discharge due to limited access to rehabilitation, creating a cycle of non-use and functional loss ("rehabilitation in vain"). The PHRASE system aims to counteract this by providing patient-tailored, continuous rehabilitation at home using the Rehabilitation Gaming System (RGS). This integrated approach leverages VR/AR technology, prognostic tools, and data-driven decision-making to improve motor and cognitive function, reduce costs, and enhance patient independence. The study seeks to validate the effectiveness of the PHRASE system, focusing on its impact on motor and cognitive recovery and its use as a diagnostic and prognostic tool. It hypothesizes that combining the RGS application with conventional therapy will lead to better recovery outcomes compared to conventional therapy alone. This randomized clinical trial (RCT) will compare the RGS-based intervention to conventional therapy in stroke patients in Spain and Romania. Participants will undergo a six-week intervention involving daily 20-30-minute RGS sessions. Assessments are at baseline, mid-study (3 weeks), end of study (6 weeks) and follow-up (14 weeks). Data will be collected on motor and cognitive function, quality of life, usability, and patient/therapist experiences. Participants must be stroke survivors (>3 months post-stroke), aged >18, with mild to moderate upper-limb impairment (ARAT <50) and minimal smartphone experience. The RGS-based PHRASE approach offers a scalable, cost-effective solution for continuous rehabilitation, improving patient recovery, quality of life, and reducing healthcare costs. The study aims to validate its clinical validity in real-world settings.

    Phase

    N/A

    Span

    27 weeks

    Sponsor

    Eodyne Systems SL

    Cluj-Napoca

    Recruiting

  • Robotic Medial Congruent Vs. Conventional Medial Pivot TKA

    This prospective, non-randomized, multicenter trial evaluates robotic-assisted (ROSA® Robotic Platform with Zimmer Biomet Persona® Medial Congruent) versus conventional (MicroPort Evolution® Medial-Pivot) total knee arthroplasty (TKA) in approximately 300 adults with severe osteoarthritis. By comparing robotic precision with a well-established Medial-Pivot design, this investigation aims to clarify whether robotic-assisted TKA confers superior implant positioning, reduced alignment outliers, and enhanced patient-reported outcomes (PROMS). The primary outcome measures include insert thickness, alignment accuracy (outliers defined as >2° from the mechanical axis on full-leg radiographs), and patient satisfaction at 6 and 12 months. Two surgeons will perform both techniques, and one surgeon will perform only the conventional procedure. The 18-month study is conducted under local Institutional Review Board approvals (Medlife, Medicover, SCJU Cluj Napoca, Monza Bucuresti) and complies with GDPR. Results are intended for publication in a high-impact orthopedic journal. No external funding is provided.

    Phase

    N/A

    Span

    84 weeks

    Sponsor

    George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

    Cluj-Napoca, Cluj

    Recruiting

  • Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

    This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.

    Phase

    3

    Span

    293 weeks

    Sponsor

    Daiichi Sankyo

    Cluj-Napoca

    Recruiting

  • A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

    Phase

    3

    Span

    148 weeks

    Sponsor

    Amgen

    Cluj-Napoca

    Recruiting

  • Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

    To the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety/and or depressive disorders that tests the accuracy of a prediction model based on fMRI to investigate participants' response to a transdiagnostic Internet-delivered intervention.

    Phase

    N/A

    Span

    65 weeks

    Sponsor

    Babes-Bolyai University

    Cluj-Napoca

    Recruiting

  • A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)

    Phase

    3

    Span

    374 weeks

    Sponsor

    Merck Sharp & Dohme LLC

    Cluj-Napoca, Cluj

    Recruiting

  • Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management

    Phase

    N/A

    Span

    142 weeks

    Sponsor

    Osoian Cristiana

    Cluj-Napoca, Cluj

    Recruiting

  • Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®

    Phase

    3

    Span

    137 weeks

    Sponsor

    Sandoz

    Cluj-Napoca

    Recruiting

  • IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

    Phase

    3

    Span

    176 weeks

    Sponsor

    Immunocore Ltd

    Cluj-Napoca

    Recruiting

  • A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

    The protocol consists of 2 studies. Study 1 includes induction and maintenance treatment, and Study 2 includes only induction treatment. Each study has its own hypotheses and outcome measures that will be assessed independently.

    Phase

    3

    Span

    321 weeks

    Sponsor

    Merck Sharp & Dohme LLC

    Cluj-Napoca, Cluj

    Recruiting

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